Achrochordon
Conditions
Keywords
skin tag
Brief summary
The objective of this study is to assess the efficacy of using the Digiclamp device to remove achrocordons (skin tags). The hypothesis is that utilizing the device will result in low rates of re-occurrence, scars, scar tissue and discoloration at the site of removal.
Detailed description
Achrocorodons, or skin tags, are superficial cutaneous lesions that occur most commonly among middle aged adults, obese persons and those who suffer from Type 2 Diabetes. In most cases, the tags are not bothersome but there are instances when they can become infected or irritated. There are several skin tag removal options available, including suture ligature, freezing, cautery or excision. These procedures are often done in a dermatology office and are an out-of-pocket cost. The Digiclamp device was invented to make skin tag removal procedures more accessible. The Digiclamp represents a new option that when placed in the hands of primary care clinicians, it will allow them to remove skin tags without having to purchase expensive devices or to refer them to a Dermatologist. The device is disposable, and relatively painless when used correctly, and requires minimal training. The investigator is planning to enroll 100 subjects, who will have skin tags removed using the Digiclamp device. Subjects will return for follow up at 2-3 months after skin tag removal.
Interventions
DEVICEDigiclamp (Skin tag removal initial plus follow-up)
Skin tag will be assessed for size, location, and overall appearance. After assessment and confirmation that the skin tag is not infected or possibly malignant, the site will be photographed, prepped with an antimicrobial solution, anesthetized, and removed using the Digiclamp. A bandaid will be applied to the site. Site of skin tag removal will be photographed to document lesion recurrence and presence of scar tissue or hyperpigmentation. Subjects will be asked to complete a brief survey about their satisfaction with the use of Digiclamp.
Sponsors
XDG Technologies, LLC
University of Florida
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Subjects with simple skin tag(s) measuring up to 1 centimeter width at the base of the skin tag
Exclusion criteria
* Subjects with skin tags measuring greater than 1 centimeter width at the base * Subjects whose skin tags appear infected or may need to be evaluated by pathology * Subjects whose skin tags are located in genital areas or eyelids * Pregnant subjects * Subjects with bleeding disorders.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Re-occurrence Rate of Skin Tags | 3 months | Percentage of subjects who experience a re-occurrence of the skin tag at the removal site. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Scar Tissue Formation Among Lesion Sites | 3 months | Percentage of subjects who develop scar tissue or keloid at the site of removal |
| Percentage of Discoloration Among Subjects | 3 months | Percentage of subjects who develop discoloration at the site of removal |
| Percentage of Pain/Numbness Where Skin Tag Was Removed | 3 months | Percentage of subjects who develop pain/numbness at the site of removal |
| Percentage of Permanent Scars Among Lesion Sites | 3 months | Percentage of subjects who develop a scar at the removal site |
| Satisfaction With What the Area Looked Like Post Procedure | 2 months post procedure | All study participants were given a satisfaction survey 2 months post procedure. Subjects had to choose if they were very satisfied:, somewhat satisfied, neither satisfied nor dissatisfied, somewhat dissatisfied, very dissatisfied with how the area looks where the skin tag used to be. Subjects in each category were counted and reported. |
| How Likely to Recommend the Procedure to Friends and Family | 2 months post procedure | All study participants were asked a satisfaction survey post procedure and whether they would recommend the procedure to friends and family. Categories for response were: very likely, somewhat likely, neither likely nor unlikely, somewhat unlikely, very unlikely. Subjects in each category were counted and reported. |
| Satisfaction With Pain Post Procedure | 2 months post procedure | All study participants were asked three questions in a post procedure satisfaction survey. 1\. How satisfied are you with the amount of pain you experienced while having your skin tag removed? Study participants responded whether they were very satisfied, somewhat satisfied, neither satisfied nor dissatisfied, somewhat dissatisfied, very dissatisfied. Subjects were counted in each category and reported. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Skin Tag Removal Initial Visit Plus Follow-up Removal of skin tags 1 cm or less using Digiclamp and follow-up 2-3 months after skin tag removal to assess functionality and effectiveness of the device.
Digiclamp (Skin tag removal initial plus follow-up): Skin tag will be assessed for size, location, and overall appearance. After assessment and confirmation that the skin tag is not infected or possibly malignant, the site will be photographed, prepped with an antimicrobial solution, anesthetized, and removed using the Digiclamp. A bandaid will be applied to the site. Site of skin tag removal will be photographed to document lesion recurrence and presence of scar tissue or hyperpigmentation. Subjects will be asked to complete a brief survey about their satisfaction with the use of Digiclamp. | 20 |
| Total | 20 |
Baseline characteristics
| Characteristic | Skin Tag Removal Initial Visit Plus Follow-up |
|---|---|
| Age, Continuous | 45.8 years STANDARD_DEVIATION 9.96 |
| Height | 66.4 inches STANDARD_DEVIATION 3.07 |
| height of lesion | 0.376 cm STANDARD_DEVIATION 0.252 |
| Location of lesions abdomen | 2 lesions |
| Location of lesions areola | 1 lesions |
| Location of lesions axilla | 7 lesions |
| Location of lesions back | 8 lesions |
| Location of lesions buttock | 1 lesions |
| Location of lesions chest | 4 lesions |
| Location of lesions mandible | 2 lesions |
| Location of lesions maxilla | 1 lesions |
| Location of lesions neck | 19 lesions |
| Location of lesions rib cage | 1 lesions |
| Location of lesions shoulder | 2 lesions |
| Location of lesions thigh | 2 lesions |
| Number of lesions | 2.5 lesions STANDARD_DEVIATION 1.15 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 20 Participants |
| Sex: Female, Male Female | 16 Participants |
| Sex: Female, Male Male | 4 Participants |
| Weight | 182 pounds STANDARD_DEVIATION 43.9 |
| width of lesion | 0.404 cm STANDARD_DEVIATION 0.276 |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 20 |
| other Total, other adverse events | 0 / 20 |
| serious Total, serious adverse events | 0 / 20 |
Outcome results
Primary
Re-occurrence Rate of Skin Tags
Percentage of subjects who experience a re-occurrence of the skin tag at the removal site.
Time frame: 3 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Skin Tag Removal Initial Visit Plus Follow-up | Re-occurrence Rate of Skin Tags | 0 Participants |
Secondary
How Likely to Recommend the Procedure to Friends and Family
All study participants were asked a satisfaction survey post procedure and whether they would recommend the procedure to friends and family. Categories for response were: very likely, somewhat likely, neither likely nor unlikely, somewhat unlikely, very unlikely. Subjects in each category were counted and reported.
Time frame: 2 months post procedure
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Skin Tag Removal Initial Visit Plus Follow-up | How Likely to Recommend the Procedure to Friends and Family | Very likely to recommend the procedure to friends and family | 20 Participants |
| Skin Tag Removal Initial Visit Plus Follow-up | How Likely to Recommend the Procedure to Friends and Family | Somewhat likely | 0 Participants |
| Skin Tag Removal Initial Visit Plus Follow-up | How Likely to Recommend the Procedure to Friends and Family | Neither likely nor unlikely | 0 Participants |
| Skin Tag Removal Initial Visit Plus Follow-up | How Likely to Recommend the Procedure to Friends and Family | Somewhat unlikely | 0 Participants |
| Skin Tag Removal Initial Visit Plus Follow-up | How Likely to Recommend the Procedure to Friends and Family | Very unlikely | 0 Participants |
Secondary
Percentage of Discoloration Among Subjects
Percentage of subjects who develop discoloration at the site of removal
Time frame: 3 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Skin Tag Removal Initial Visit Plus Follow-up | Percentage of Discoloration Among Subjects | 3 Participants |
Secondary
Percentage of Pain/Numbness Where Skin Tag Was Removed
Percentage of subjects who develop pain/numbness at the site of removal
Time frame: 3 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Skin Tag Removal Initial Visit Plus Follow-up | Percentage of Pain/Numbness Where Skin Tag Was Removed | 0 Participants |
Secondary
Percentage of Permanent Scars Among Lesion Sites
Percentage of subjects who develop a scar at the removal site
Time frame: 3 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Skin Tag Removal Initial Visit Plus Follow-up | Percentage of Permanent Scars Among Lesion Sites | 1 Participants |
Secondary
Percentage of Scar Tissue Formation Among Lesion Sites
Percentage of subjects who develop scar tissue or keloid at the site of removal
Time frame: 3 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Skin Tag Removal Initial Visit Plus Follow-up | Percentage of Scar Tissue Formation Among Lesion Sites | 0 Participants |
Secondary
Satisfaction With Pain Post Procedure
All study participants were asked three questions in a post procedure satisfaction survey. 1\. How satisfied are you with the amount of pain you experienced while having your skin tag removed? Study participants responded whether they were very satisfied, somewhat satisfied, neither satisfied nor dissatisfied, somewhat dissatisfied, very dissatisfied. Subjects were counted in each category and reported.
Time frame: 2 months post procedure
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Skin Tag Removal Initial Visit Plus Follow-up | Satisfaction With Pain Post Procedure | Very satisfied | 20 Participants |
| Skin Tag Removal Initial Visit Plus Follow-up | Satisfaction With Pain Post Procedure | Somewhat satisfied | 0 Participants |
| Skin Tag Removal Initial Visit Plus Follow-up | Satisfaction With Pain Post Procedure | Neither satisfied nor dissatisfied | 0 Participants |
| Skin Tag Removal Initial Visit Plus Follow-up | Satisfaction With Pain Post Procedure | Somewhat dissatisfied | 0 Participants |
| Skin Tag Removal Initial Visit Plus Follow-up | Satisfaction With Pain Post Procedure | Very dissatisfied | 0 Participants |
Secondary
Satisfaction With What the Area Looked Like Post Procedure
All study participants were given a satisfaction survey 2 months post procedure. Subjects had to choose if they were very satisfied:, somewhat satisfied, neither satisfied nor dissatisfied, somewhat dissatisfied, very dissatisfied with how the area looks where the skin tag used to be. Subjects in each category were counted and reported.
Time frame: 2 months post procedure
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Skin Tag Removal Initial Visit Plus Follow-up | Satisfaction With What the Area Looked Like Post Procedure | Very satisfied with how the area looked like where the skin tag used to be | 19 Participants |
| Skin Tag Removal Initial Visit Plus Follow-up | Satisfaction With What the Area Looked Like Post Procedure | Somewhat satisfied with what the area looked like | 1 Participants |
| Skin Tag Removal Initial Visit Plus Follow-up | Satisfaction With What the Area Looked Like Post Procedure | Neither satisfied nor dissatisfied | 0 Participants |
| Skin Tag Removal Initial Visit Plus Follow-up | Satisfaction With What the Area Looked Like Post Procedure | Somewhat dissatisfied | 0 Participants |
| Skin Tag Removal Initial Visit Plus Follow-up | Satisfaction With What the Area Looked Like Post Procedure | Very dissatisfied | 0 Participants |